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510(k) K863408

EBV/VCA-CHECK(TM) ANTIGEN SLIDES by Diagnostic Technology, Inc. — Product Code GNP

K863408 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "EBV/VCA-CHECK(TM) ANTIGEN SLIDES". The FDA issued a decision of Substantially Equivalent on November 28, 1986. The device falls under product code GNP (Antiserum, Cf, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1986
Date Received
September 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Diagnostic Technology, Inc.

  • K896378 — LYME-CHECK(TM) TEST KIT (November 5, 1991)
  • K903612 — EBV/EA-CHECK TM TEST KIT (October 16, 1990)
  • K890819 — HSV-CHECK(TM) TEST KIT (June 20, 1989)
  • K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT (June 20, 1989)
  • K891542 — EBNA-CHECK(TM) TEST KIT (June 20, 1989)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)
  • K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (May 7, 1986)
  • K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (April 4, 1986)
  • K853036 — PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 (November 5, 1985)

Other clearances for product code GNP

  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)
  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (June 13, 2002)
  • K981829 — IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (February 16, 1999)
  • K981831 — IS EBV-EA-D IGG ELISA TEST SYSTEM (February 16, 1999)
  • K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K880885 — EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (August 30, 1988)
  • K880883 — EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (August 30, 1988)

FDA data resources